12.1. Devices incorporating electronic programmable systems must be designed to ensure the repeatability, reliability and performance of these systems according to the intended use. In …

2011年3月30日 · Article 12, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Particular Procedure for Systems and Procedure …

HIGH-DENSITY STORAGE - 12TB hard disk drive designed for Hyperscale applications/cloud data centers solutions requiring maximum storage efficiency. 3.5-inch form factor for space …

2007年10月11日 · This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right.

the MDD. In layman’s terms, the Design Dossier is the Technical Documentation plus a summary of the history of design changes for the device. • Equivalent to the US FDA’s requirements for …

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Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by …

Die Anwendung dieser Anhänge und die Beteiligung der benannten Stelle sind auf die Aspekte des Sterilisationsverfahrens zur Erreichung der Sterilität des Produktes bis zur Öffnung oder …

Built to support enterprise-class nearline workloads of 550TB/yr, and backed by 2M hours MTBF as well as a 5-Year Limited Warranty, the Enterprise Capacity 3.5 HDD helps to ensure you …